A Single-Dose, Randomized, Double-Blind, Placebo- and Positive-Controlled, 4-Way Crossover Study to Evaluate the Effect of Enpatoran on the QTc (Corrected QT) Interval in Healthy Adult Participants
Sponsor study identifier
Secondary identifiers
OTHER · EU CT Number
interventional
40
1 country
1
Study Start
September 10, 2024
Actual (reported)Primary Completion
December 2, 2024
Actual (reported)Study Completion
December 2, 2024
Actual (reported)The purpose of this study is to assess potential effects of enpatoran on cardiac repolarization (i.e. prolongation of QT interval).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 6, 2024
Actual (reported)September 10, 2024
Actual (reported)September 19, 2024
Actual (reported)December 2, 2024
Actual (reported)December 2, 2024
Actual (reported)Placebo-Corrected Change from Baseline in Heart Rate-Corrected QT Interval by Fridericia's Formula (QTcF) for Enpatoran
Pre-dose on Day 1 (baseline) up to 24 hours post-dose
Placebo-Corrected Change from Baseline in Heart Rate-Corrected QT Interval by Fridericia's Formula (QTcF) for Moxifloxacin
Pre-dose on Day 1 (baseline) up to 24 hours post-dose
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Up to approximately 72 days
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by Severity
Up to approximately 72 days
Number of Participants with Abnormal Laboratory Parameters, Vital Signs and 12-Lead Electrocardiogram (ECG) Findings
Up to approximately 72 days
ECG Parameters: QT Interval, heart rate-corrected QT interval (QTc), individual corrected QT interval (QTcI), PR Interval, QRS interval and RR Interval
Pre-dose up to 24 hours post-dose
Participants will receive a single oral dose of placebo matched to enpatoran (Treatment A) in treatment period 1, followed by a single oral dose of moxifloxacin tablet (Treatment B) in treatment period 2, followed by a single oral low dose of enpatoran tablet (Treatment C) in treatment period 3, followed by a single oral high dose of enpatoran tablet (Treatment D) in treatment period 4. There will be a washout period of at least 10 days between each treatment period.
Participants will receive a single oral dose of moxifloxacin tablet (Treatment B) in treatment period 1, followed by a single oral high dose of enpatoran tablet (Treatment D) in treatment period 2, followed by a single oral dose of placebo matched to enpatoran (Treatment A) in treatment period 3, followed by a single oral low dose of enpatoran tablet (Treatment C) in treatment period 4. There will be a washout period of at least 10 days between each treatment period.
Participants will receive a single oral dose of placebo matched to enpatoran in either of treatment period 1, 2, 3 and 4.
Nuvisan GmbH
Neu-Ulm, Germany
Medical Responsible
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
40 participants (actual enrollment reported by the registry).
First Submitted
September 6, 2024
First Posted
September 19, 2024
Study Start
September 10, 2024
Actual (reported)T/QT Study to Investigate the Effect of Relacorilant on Cardiac Repolarization in Healthy Volunteers
Participants will receive a single oral low dose of enpatoran tablet (Treatment C) in treatment period 1, followed by a single oral dose of placebo matched to enpatoran (Treatment A) in treatment period 2, followed by a single oral high dose of enpatoran tablet (Treatment D) in treatment period 3, followed a by single oral of moxifloxacin tablet (Treatment B) in treatment period 4. There will be a washout period of at least 10 days between each treatment period.
Participants will receive a single oral high dose of enpatoran tablet (Treatment D) in treatment period 1, followed by a single oral low dose of enpatoran (Treatment C) in treatment period 2, followed by a single oral dose of moxifloxacin tablet (Treatment B) in treatment period 3, followed by a single oral dose of placebo matched to enpatoran (Treatment A) in treatment period 4. There will be a washout period of at least 10 days between each treatment period.
Participants will receive a single oral dose of moxifloxacin tablet (Treatment B) in either of treatment period 1, 2, 3 and 4.
Participants will receive a single oral low dose of enpatoran tablet (Treatment C) in either of treatment period 1, 2, 3 and 4.
Participants will receive a single oral high dose of enpatoran tablet (Treatment D) in either of treatment period 1, 2, 3 and 4.
Contact the study team to confirm eligibility.
Primary Completion
December 2, 2024
Actual (reported)Study Completion
December 2, 2024
Actual (reported)Last Updated
December 19, 2024
Record last verified: 2024-12
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